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Method for rapid detection of vardenafil hydrochloride

A technology of vardenafil hydrochloride and detection equipment, applied in the direction of electrochemical variables of materials, etc., can solve the problems of total dissolved solids that interfere with the conductivity of the sample solution, unsatisfactory effect, technical difficulties, etc.

Active Publication Date: 2017-03-08
BEIJING INST FOR DRUG CONTROL
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

Then, is it possible to directly use the electrochemical method of detecting the conductivity or total dissolved solids in water to detect impotence drugs, health products or foods suspected of adding vardenafil hydrochloride? It was found that the effect was not ideal, because vardenafil hydrochloride may be added to aphrodisiac drugs, health products, or complex matrix in food containing other hydrophilic substances and lipophilicity, which will seriously interfere with the conductivity and solution of the sample solution. Total Dissolved Solids (TDS) in , resulting in no correlation with whether or not vardenafil hydrochloride was added
Therefore, it is technically difficult to directly detect whether vardenafil hydrochloride is illegally added to aphrodisiac drugs, health products or foods by electrochemical methods that detect the conductivity or total dissolved solids in the solution.

Method used

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  • Method for rapid detection of vardenafil hydrochloride

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0064] Embodiment 1, the general operation method of detecting whether vardenafil hydrochloride is contained in products such as medicine / health product food

[0065] 1. Sampling volume:

[0066] Sampling recommendations for different types of samples are as follows:

[0067] sample type Sampling volume tablet Two oral doses (must be crushed) Capsules Two oral doses (take the contents and grind them) water pill Two oral doses (must be crushed) Granules Two oral doses (must be crushed) other solid Two oral doses (must be crushed)

[0068] This shows that the amount of the product to be tested used in the method of the present invention is few, so that the interests of innocent operators are damaged as little as possible, the preparation weight of the above various types of samples is usually about 0.5~5g, such as capsules, The weight of the preparation for two doses of tablets is usually about 0.5 g, while the weight of the p...

Embodiment 3

[0075] Embodiment 3, test whether there is vardenafil hydrochloride in medicine, health food and food

[0076] 1. Adopt the method of embodiment 1 to detect 20 batches of samples rapidly (all are the sampling samples of drug supervision department).

[0077] 2. Verify whether vardenafil hydrochloride is contained in each test sample according to the following HPLC method in addition, to judge the accuracy of the method of the present invention:

[0078] Instruments and conditions: Shimadzu LC-10AD / SIL-10AD / SPD-M10A / SCL-10A / DGU-14A high-performance liquid chromatography and Shimadzu workstation; use octadecylsilane bonded silica gel as filler (C18 Column, 4.6mm×25cm×5μm, THERMO); with 1g / L ammonium acetate solution (take 1g of ammonium acetate, add about 900ml of water to dissolve, shake well, adjust the pH value to 3.8 with glacial acetic acid, add water to dilute to 1000ml): Methanol =70:30 (v / v) is the mobile phase; the detection wavelength is 277nm; the column temperatur...

Embodiment 4

[0093] Embodiment 4, the performance of the inventive method

[0094] The performance of the method of the present invention is investigated according to the determination method of the detection limit according to the routine detection method in the field of drug testing.

[0095] Vardenafil hydrochloride clinical single dose is 5mg, TDS of the present invention and conductivity measurement all show that the sensitivity of the present invention's method detection vardenafil hydrochloride can reach 24% of clinical single dose at least (in fact under this dose It is difficult to obtain the clinical effect of vardenafil hydrochloride, and it is meaningless for adulterers to add such an amount of medicine, they usually add 5 mg or more if vardenafil hydrochloride is added), and there is no false result, that is There is no inconsistency between the result judged by the method of the present invention and the chromatographic result. It shows that the method of the present inven...

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Abstract

The invention relates to a method for detecting vardenafil hydrochloride and in particular relates to a method for rapidly detecting vardenafil hydrochloride which is illegally added into Yang-tonifying type medicines, health products or foods and other products. The invention particularly relates to a method for detecting whether vardenafil hydrochloride is contained in a product which is suspected to be adulterated with vardenafil hydrochloride or not. The method comprises the following steps: (1) taking a proper amount of product, mixing with a special solvent, shaking or performing ultrasonic-assisted dissolving, thereby obtaining a mixed test solution; (2) measuring specific electrochemical parameters of the mixed test solution by adopting a proper a detector based on a specific electrochemical principle; and (3) judging whether the vardenafil hydrochloride is illegally added into the product or not according to the parameter value. According to the method disclosed by the invention, a sample solution does not need to be filtered, only 2-3 minutes needs to be consumed in the whole detection process, and the method has the advantages of rapidness, simplicity, safety, high sensitivity, environment friendliness and the like.

Description

technical field [0001] The invention relates to the technical field of analysis of medicines, health foods or foods, in particular to a method for quickly screening illegally added vardenafil hydrochloride in medicines, health foods or foods based on electrochemical principles. Background technique [0002] Vardenafil hydrochloride (Vardenafil, HCl) is the latest drug in the field of erectile dysfunction (ED) treatment in the world. It was developed by German Bayer and Glaxo Smith Kline after many years. , works by inhibiting phosphodiesterase type 5 (PDE-5). Compared with sildenafil (Viagra), it has the following advantages: less dosage, only 20mg (sildenafil needs 120mg- 150mg). Fast onset time, effective within 15 to 30 minutes. The side effects are small, but due to individual differences, less than 2% of people still experience mild headaches. The duration can reach more than 6 hours. The launch of vardenafil has made the current international advanced aphrodisiac ra...

Claims

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Application Information

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Patent Type & Authority Patents(China)
IPC IPC(8): G01N27/26
Inventor 胡琴杨文良车宝泉王铁松吴斌纪菁尹光
Owner BEIJING INST FOR DRUG CONTROL
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